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The Fourth Amendment of the Patent Law
On October 17, 2020, the 22nd Session of the Standing Committee of the 13th National People's Congress passed the decision on Amending the patent law of the people's Republic of China. The revised Patent Law will be implemented on June 1, 2021. This is the fourth Amendment of the patent law of China, with 29 amendments in total. This Amendment mainly focuses on three aspects: strengthening the protection of patent rights, promoting the transformation and application of patents, and improving the patent authorization system. First of all, the Amendment strengthens the protection of the legitimate rights of patentees. In the Amendment, it is stipulated that "For willful patent infringement with serious circumstances, the amount of compensation shall be determined ranging from one to five times the amount of compensation determined by the preceding methods. Where it is difficult to determine the losses suffered by the patentee, the profits which the infringer has earned through the infringement and royalties, the people's court may set an amount of compensation of no more than RMB 5,000,000 in light of factors such as the type of the patent right, the nature of the infringing act and the circumstances. "This Amendment not only increases the statutory compensation limit stipulated in the original Patent Law, the lower limit is increased from 10,000 to 30,000, and the upper limit is increased from 1 million to 5 million; it also provides for the implementation of a punitive compensation system for serious infringement of patent rights, and the compensation can be up to 5 times. The addition of punitive compensation and the increase of statutory compensation will be conducive to the protection of the legitimate rights of patentees. It also increases the cost of infringement. In addition to increasing the compensation, the Amendment also stipulates that: "In order to determine the amount for compensation, under the circumstances in which the right holder has endeavored to present evidence, and the related account books or materials are mainly in control by the accused infringer, the people's court may order the accused infringer to provide account books and materials relating to the infringing conduct; if the accused infringer does not provide or provides false account books or materials, the people's court may refer to the right holder's claims and evidence to rule on the amount of compensation. "This provision improves the rule of evidence and reduces the burden of proof on the obligee. Secondly, this Amendment adds the open license system, which stipulates: "Where the patentee declares in writing to the administrative department for patent under the State Council that he is willing to license any entity or individual to exploit his or her patent, and specifies the method and standard for payment of the licensing fee, the administrative department for patent under the State Council shall make an announcement and implement an open license. Where an opening license declaration is made on a patent for utility model or design, a patent evaluation report shall be provided." In order to encourage patentees to implement open licenses, the law also stipulates that the annual patent fees paid by the patentees will be reduced during the period of the open license. Although there are many patent applications in China, the patent conversion rate is low. The open license system can make the patentee reach a license agreement with many people, which can effectively promote the implementation of patents and accelerate the transformation of innovation achievements. Thirdly, this Amendment has also improved the patent authorization system. This Amendment improves the relevant system for the protection of design patents and adds the domestic priority to design patents. It stipulates that "where an applicant claims the priority of a design patent, he / she shall make a written declaration at the time of application and submit a copy of the patent application document for the first time within three months." Besides, the term of protection for design patents has been extended from 10 years to 15 years. In addition to the three aspects above, this Amendment also adds new provisions on the compensation period of drug patents. It provides that "The State Council may make a decision to extend the duration of invention patents of innovative pharmaceuticals which have been approved for marketing in China, to make up the time used for drug approval, and the extension period shall not exceed five years and the net effective duration of such innovative pharmaceuticals which have market launches shall not exceed fourteen years." Compared with the patents in other industries, drug patents have their own characteristics. When the drug is finally put on the market, the patent period included in the drug is not long, and the interests of the R & D pharmaceutical factory are not well protected. The newly-added drug patent compensation perio
Details 白箭头 黑箭头
《生物安全法》表决通过,后疫情时代的重要法典!
10月17日,十三届全国人大常委会第二十二次会议表决通过了生物安全法并自2021年4月15日起施行。这是我国首部有关生物安全的法律,今年爆发的新型冠状病毒疫情给全球带来了严重的灾难,虽然目前中国的疫情得到有效的控制,但是全球的局势依旧很严峻,本次疫情让公众了解到生物安全不仅影响个体生命安全,更关乎国家公共安全,关乎人类安全。当前,随着气候的极端变化,自然环境的恶化以及人类活动流动性加大,全球生物安全的问题愈加突出,重大人类传染病、动植物疫情不断发生,生物安全的形势日益严峻,《生物安全法》的诞生顺应了时代的要求。 一、生物安全的内容 生物安全是国家安全的重要组成部分,是指国家有效防范和应对危险生物因子及相关因素威胁,生物技术能够稳定健康发展,人民生命健康和生态系统相对处于没有危险和不受威胁的状态,生物领域具备维护国家安全和持续发展的能力。与生物安全相关的活动主要包括这些内容:(一)防控重大新发突发传染病、动植物疫情;(二)生物技术研究、开发与应用;(三)病原微生物实验室生物安全管理;(四)人类遗传资源与生物资源安全管理;(五)防范外来物种入侵与保护生物多样性;(六)应对微生物耐药;(七)防范生物恐怖袭击与防御生物武器威胁;(八)其他与生物安全相关的活动。 二、《生物安全法》对维护国家生物安全的作用性 《生物安全法》是生物安全领域的基础性法律,其颁布和实施必将产生积极而深远的影响:一是有利于保障人民生命安全和身体健康。生物安全法将保障人民生命健康作为立法宗旨,明确维护生物安全应当坚持以人为本的原则,在防范和应对各类生物安全风险时,始终坚持人民至上、生命至上。二是有利于维护国家安全。生物安全法明确生物安全是国家安全的重要组成部分,把生物安全纳入国家安全体系进行谋划和布局,明确生物安全管理体制机制。三是有利于提升国家生物安全治理能力。该法要求政府支持生物安全事业发展,鼓励生物科技创新和生物产业发展,加强人才培养和物资储备,统筹布局生物安全基础设施建设,加强国家生物安全风险防控和治理体系建设,提升国家生物安全治理能力。 三、《生物安全法》建立了完善的生物安全风险防控体制 该法建立了建立统一领导、协同联动、有序高效的生物安全风险防控体制,从国家部委、地方各级人民政府、基层群众性自治组织到有关单位和个人,动员社会力量依法有序参与生物安全风险防控工作。一是由国务院卫生健康、农业农村、科学技术、外交等主管部门和有关军事机关组成国家生物安全工作协调机制,分析、研判国家生物安全形势,组织协调、督促推进国家生物安全相关工作。国家生物安全工作协调机制设立办公室,负责协调机制的日常工作;二是地方各级人民政府对本行政区域内生物安全工作负责,县级以上地方人民政府有关部门根据职责分工,负责生物安全相关工作;三是基层群众性自治组织应当协助地方人民政府以及有关部门做好生物安全风险防控、应急处置和宣传教育等工作;四是有关单位和个人应当配合做好生物安全风险防控和应急处置等工作。 同时由国家建立生物安全风险监测预警制度和风险调查评估制度,根据风险监测的数据、资料等信息,定期组织开展生物安全风险调查评估。国家生物安全工作协调机制组织建立统一的国家生物安全信息平台,有关部门应当将生物安全数据、资料等信息汇交国家生物安全信息平台,实现信息共享。 四、违反《生物安全法》的行为及相应的法律责任 违反《生物安全法》的行为主要是在生物安全相关的活动中产生,包括以下几种:(一)生物安全管理职责的工作人员在生物安全工作中滥用职权、玩忽职守、徇私舞弊或者有其他违法行为的,依法给予处分;(二)医疗机构、专业机构或者其工作人员瞒报、谎报、缓报、漏报,授意他人瞒报、谎报、缓报,或者阻碍他人报告传染病、动植物疫病或者不明原因的聚集性疾病的,依法给予责令改正、警告、暂停执业、吊销执业证书等处罚;(三)从事国家禁止的生物技术研究、开发与应用活动或者从事病原微生物实验活动未在相应等级的实验室进行等,给予警告、罚款等处处罚;(四)购买或者引进列入管控清单的重要设备、特殊生物因子未进行登记以及个人购买或者持有列入管控清单的重要设备或者特殊生物因子等行为,给予没收违法所得、警告、罚款等处罚;(五)境外组织、个人及其设立或者实际控制的机构在我国境内采集、保藏我国人类遗传资源,或者向境外提供我国人类遗传资源的行为,给予没收违法所得、罚款等处罚;(六)未经批准,擅自引进外来物种的行为,给予没收引进的外来物种、罚款等处罚。同时该法规定,构成犯罪的,依法追究刑事责任;造成人身、财产或者其他损害的,依法承担民事责任。 近期频发的国际国内生物安全事件,例如非洲猪瘟、非洲蝗灾、美国流感、新型冠状病毒等等,给人类社会带来了严重的灾难,《生物安全法》把生物安全纳入国家安全体系,将生物安全升级为国家大战略,是维护国家安全的重大举措。疫情之后,国内生物安全领域将迎来一次政策的全面推动。该法将成为防范和应对生物安全风险、保障人民生命健康、保护生物资源和生态环境、维护国家安全的一部重要法律。
Details 白箭头 黑箭头
Inmazeb, the First FDA Approved Treatment for Ebola Virus
On October 14, the U.S. Food and Drug Administration approved Regeneron’s Inmazeb as the first FDA-approved treatment for Ebola virus infection in adult and pediatric patients. Zaire ebolavirus, commonly known as Ebola virus, can cause a potentially fatal human disease. Ebola virus is transmitted through direct contact with blood, body fluids and tissues of infected people or wild animals, as well as with surfaces and materials, such as bedding and clothing, contaminated with these fluids. Individuals who provide care for people with Ebola virus, including health care workers who do not use correct infection control precautions, are at the highest risk for infection. Ebola is the cause of a viral hemorrhagic fever disease (Ebola virus disease, or EVD). The viruses that cause EVD are well known to be located mainly in sub-Saharan Africa. Inmazeb, formerly known as REGN-EB3, is developed by Regeneron Pharmaceuticals, and is a mixture of the following three monoclonal antibodies: atoltivimab, maftivimab, and odesivimab-ebgn. Inmazeb targets the glycoprotein that is on the surface of Ebola virus. Glycoprotein attaches to the cell receptor and fuses the viral and host cell membranes allowing the virus to enter the cell. The three antibodies that make up Inmazeb can bind to this glycoprotein simultaneously and block attachment and entry of the virus. Inmazeb once received an Orphan Drug designation for the treatment of Ebola virus infection. Additionally, the FDA previously granted Inmazeb a Breakthrough Therapy designation for the treatment of Zaire ebolavirus infection. “Today’s approval highlights the importance of international collaboration in the fight against Ebola virus,” said John Farley, M.D., MPH, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. “The urgent need for advanced therapies to combat this infectious disease is clear, and today’s action is a significant step forward in that effort.”
Details 白箭头 黑箭头
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